Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy

NCT03831113 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: STUDY19100128R01HD096796
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a pharmacodynamic study in pregnant women evaluating the relationship between buprenorphine concentration and outcome such as opioid withdrawal symptoms , NAS scores, neurodevelopmental and neuroanatomic outcomes. Strategies to reduce opioid exposure will be explored. There are 4 specific aims but only specific aim 4 is a clinical trial and reported here. In specific aim 4, eligible consenting women on buprenorphine in an MAT clinic will be assigned to 2 dose reduction regimens and their response to dose reduction will be measured using a visual analog scale.

Conditions

Opiate Addiction; Pregnancy

Keywords

Buprenorphine; medication-assisted treatment (MAT) programs

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) Scores

  The VAS questionnaire consists of 4 questions related to cravings (0 = not at all to 10 = very much), withdrawal (0 = no symptoms to 10 = symptoms all day), sleep quality (0 = best to 10 = worst), and sleep duration (0 = longest ever to 10 = shortest ever). The 4 component questions are summed to provide a single VAS score for that day. The daily scores are averaged over the week or for two weeks depending on how often the dose was changed. The average VAS scores for each reduction regimen are averaged and compared to the alternative dosing group.

  36 weeks

Study Arms (2)

Magnitude Group

ACTIVE COMPARATOR

Subjects will receive alternating reductions of 1 mg or 2 mg weekly.

Drug: Magnitude Group

Frequency Group

ACTIVE COMPARATOR

Subjects will receive dose reductions of 2 mg on alternating intervals of 1 and 2 weeks.

Drug: Frequency Group

Interventions

Magnitude Group DRUG

Dose reductions will alternate between 1mg or 2 mg weekly until the subject is no longer taking buprenorphine or is at the lowest tolerable dose.

Also known as: magnitude

Magnitude Group

Frequency Group DRUG

Dose reductions of 2 mg will occur alternate between once weekly to biweekly until the subject is no longer taking buprenorphine or is at the lowest tolerable dose.

Also known as: frequency

Frequency Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women who have been prescribed buprenorphine by a Medication Assisted Treatment (MAT) clinic.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• On a stable dosing regimen of BUP for at least 2 weeks as part of an established medication- assisted treatment (MAT) program.
• Willingness to undergo supervised dose reduction
• Subject willingness to be assigned to either the Magnitude, or Frequency group.
• Single gestation between 14-30 weeks at the initiation of the dose reduction
• On a BUP dose between 6- 24 mg daily (lower doses will not provide sufficient data points)
• Willingness to have urine samples tested for drugs of abuse and blood samples tested for BUP+M concentrations during the Medical Supervised Withdrawal (MSW) clinic appointments
• Willingness to attend weekly or biweekly MSW clinic appointments and to have daily contact via text messaging and to complete daily logs of sleep quality, withdrawal symptoms and symptoms of craving.
• Willingness to attend psychosocial support meetings as needed.

You may not qualify if:

• Current use of cocaine, heroin, benzodiazepines, barbiturates, phencyclidine (PCP), or opioids other than BUP.
• Currently taking more than two mental health medications
• Active moderately severe depression (PHQ-9 score ≥15 or suicidal ideation)
• Current incarceration
• Lack of a phone or transportation to and from clinic
• Major fetal malformation
• Mother with significant vaginal bleeding or serious medical or obstetrical complication that could adversely affect the study
• Planned delivery at another institution
• HIV or AIDS
• Diagnosis of schizoaffective disorder or psychosis

Sponsors & Collaborators

• Steve N. Caritis, MD: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Univerity of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

High Risk Obstetrical Consultants

Knoxville, Tennessee, 39720, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Short Stature, Auditory Canal Atresia, Mandibular Hypoplasia, Skeletal Abnormalities

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

This portion of the study was terminated due to poor recruitment and poor compliance of recruited subjects

Results Point of Contact

• Title: Dr Steve Caritis
• Organization: University of Pittsburgh

scaritis@mail.magee.edu

412 641 4874

Study Officials

• Steve Caritis, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of OB/Gyn/RS

Model Details: dose reductions will alternate between 1 or 2 mg weekly (magnitude group) or 2 mg reductions every 1 or 2 weeks (frequency group)

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 5, 2019
• Study Start: April 13, 2019
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: August 29, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)